Events

Retiro De Equipo (Recall) de Cobas e 801 Analytical Unit. An in vitro diagnostic medical device.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00215-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-04
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00215-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Roche has identified an issue with the syringe plunger on the cobas e 801 analytical unit prewash (pw) syringe assembly. this issue may also occur on the instrument’s r1 or r2 reagent syringe assembly. investigations by the manufacturer have determined that depending on the affected syringe, r1, r2 or prewash liquids may not be pipetted correctly.In the worst case scenario during the cobas e 801 analytical unit initialisation steps, the plunger may crack leading to an impaired syringe function. this may affect the pipetting as follows:- if the prewash syringe plunger is broken, the cobas e 801 module cannot detect it and no alarm is issued. in this instance, the prewash step required by most assays will not be performed and an impact on measurement results cannot be excluded.- if the r1 or r2 syringe plunger is broken, a system alarm "345-1 warning abnormal low signal" is generated and data alarm (.
  • Acción
    Roche Diagnostics has contacted affected sites and arranged for the installation of a hardware modification kit which ensures correct positioning and movement of the syringe plungers to prevent the issue from occurring.

Device

Cobas e 801 Analytical Unit. An in vitro diagnostic medical device.
  • Modelo / Serial
    Cobas e 801 Analytical Unit. An in vitro diagnostic medical device.Material Number: 07682913001Serial Numbers: 1601-01 to 18E6-10Affected Part: Plunger (798-3203) ARTG: 173887Roche Diagnostics Australia - Instrument/analyser IVDs
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited